| Class 2 Device Recall Stryker Howmedica Osteonics Corp. | |
Date Initiated by Firm | December 20, 2012 |
Date Posted | March 08, 2013 |
Recall Status1 |
Terminated 3 on September 30, 2015 |
Recall Number | Z-0919-2013 |
Recall Event ID |
64306 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
|
Product | Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100 |
Code Information |
Catalog Number: 6266-0-100 Lot Code: RD6W017, RD7L234X, RD7L234, RD7L235, RD5T305A, RD6W017J, RD6W017A, RD5T307, RD5T305T, RD5T305M, RD5T305L, RD5T306X, RD5T305, RD5T306 |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah NJ 07430
|
For Additional Information Contact | 201-831-5523 |
Manufacturer Reason for Recall | Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use. |
FDA Determined Cause 2 | Process control |
Action | Stryker Orthopaedics sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" dated December 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at (201) 972-2100 for questions regarding this issue. |
Quantity in Commerce | 48 units |
Distribution | Nationwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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